BJ Medical College and Sassoon General Hospital (SGH) has successfully reported through a trial that with better drugs the tuberculosis (TB) treatment trial could be shortened from the current six months course to four months. This will not only be cost effective for patients, but also be less damaging due to the reduced drug usage and the adverse effects caused by the same. The study was conducted over two years and has been found to be effective for mass treatment too. The hospital’s pulmonary department had collaborated with the World Health Organisation and US Centre for Disease Control and Prevention (CDC).
The SHINE trial or Shorter Treatment for Minimal Tuberculosis in Children was termed as successful during the virtual 51st union conference on lung health which was organised in October. The trial showed that a shortened four-month regiment of the drugs, namely rifampicin, isoniazid, pyrazinamide plus or minus ethambutol in children with smear-negative, non-severe TB was as much effective as the current and standard six-month treatment, with no difference in adverse events. These findings have the potential to change current treatment guidelines for children with drug-susceptible TB. The trial was conducted on 86 participants in SGH.
The WHO noted, “Long treatment regimens can result in high costs to families and health services, potentially with added toxicity, risks of drug-drug interactions in children living with HIV, and problems with pill-burden and adherence.”
Dr Murlidhar Tambe, dean of BJMC and SGH, said, “India assumes the world’s largest burden of tuberculosis, and the treatment is prolonged and difficult—particularly for children. Our team is proud to have contributed to findings that shorten the length of treatment, and we are grateful to the families who participated in this important effort.”
Dr Samir Joshi, who was also involved with the study, said, “We found promising results in a shorter time with changed drugs specifically rifampicin which was earlier expensive but over time has become cheaper. This is time and cost saving for the monitoring doctors and patients too, who do not have to travel repeatedly to the hospital for regular follow up. Also, reduced use of drugs means that it is less damaging to the patients. We would also recommend it for mass treatment, however, it is the call of the government.”
The team from India included BJGMC JHU-India SHINE team members, Dr Aarti Kinikar-BJGMC principal investigator; Dr Vidya Mave- JHU Pune principal investigator; Dr Priyanka Raichur- study coordinator; Dr Mandar Paradkar; Savita Kanade; Aparna Nijampurkar; Vandana Kulkarni and Neeta Pradhan.
A similar study by BJGMC also found that the four month course of daily TB treatment is as effective as six months in adults. The results of a Phase 3 trial found that a daily regimen of high-dose rifapentine with moxifloxacin administered over four-months is as effective as the current six-month standard of care. With no difference in adverse events, the shortened treatment is just as safe. The study enrolled more than 2,500 participants from clinical sites in 13 countries, including the BJGMC-JHU-India clinical research site in Pune, where 61 participants were enrolled, which was the largest drug-susceptible TB treatment trial ever conducted by CDC or NIAID.
Doctors from SGH said that for the adults’ study, the team included Dr Sanjay Gaikwad; Dr Lokhande; Dr Vidya Mave; Dr Nishi Suryavanshi; Dr Neetal Nevrekar; Dr Sandesh Patil; Vandana Kulkarni; Neeta Pradhan; Savita Kanade; Sadaf Inamdar; Sameer Khan; Smita Nimkar and Sapna Adhav.